Chloramphenicol eye drops POM to P consultation starts
Consultation on the reclassification of chloramphenicol eye drops (0.5 per cent) from prescription-only medicine to pharmacy medicine began last week. The Medicines and Healthcare products Regulatory Agency will be seeking comments until 20 January 2005.
Chloramphenicol eye drops are already supplied by optometrists and some
pharmacists via patient group directions or through supplementary prescribing.
The training that pharmacists will need to undertake to supply chloramphenicol
without prescription is outlined in the consultation document and emphasises
the need to be able to identify more serious eye conditions that require
referral to a GP. The document also addresses a number of specific concerns
about the ramifications of reclassifying chloramphenicol, including safety
concerns, such as bone marrow toxicity, “grey baby” syndrome
and resistance, stating that the available evidence “supports the
view that bacterial resistance would not be affected by pharmacy availability”.
Commenting on the consultation, David Pruce, director of practice and quality
improvement at the Royal Pharmaceutical Society, said: “Pharmacists have
long believed that making this product available from a pharmacy without the
need for a prescription would be a safe, effective and far more convenient route
to treatment for the many patients who visit pharmacies every day with bacterial
conjunctivitis.”
John Blenkinsopp, independent consultant to the pharmaceutical industry and soon
to join Keele University’s department of medicines management as a senior
research fellow, said the simplification of the POM to P switching process and
extension of exclusivity periods have meant that the pharmaceutical industry
is increasingly considering POM to P switching.
He expects a further five POM to P switches to occur either before Christmas
or early in 2005.
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